Hair loss is impacting job opportunities, relationships, mental wellbeing and self-confidence. It is common that, as people age, hair growth slows down. However, the phenomenon of hair loss can be due to many other causes also. Some of them are pathological or external or diet related, with effects on hair growth that vary depending on the evolution of the related disease or external event.
Alopecia (hair loss) can be classified as being one of two types: non-scarring alopecia and scarring alopecia. Non-scarring alopecia has been attributed to:                Genetics and advanced age (i.e. androgenetic alopecia, female pattern hair loss)        High fevers, severe infections, thyroid disease        Childbirth, taking birth control pills        Inadequate proteins or iron in diet        Patients on drugs like blood thinners, treatments for gout, arthritis, depression, hypertension, chemotherapy        Alopecia areata        Physical or emotional stress        Topical use of chemical treatments, such as hair dyes, permanent wave solutions, etc.        Diseases, such as leprosy or syphilis        Allergy        
Scarring alopecia may be a consequence of burns (accidental or post-surgical from cryosurgery or laser surgery) or trauma, which often causes destruction of hair follicles.
The most common cause of baldness or hair loss (95%) is however, the so called Androgenetic alopecia, that is the well-known tendency to baldness or thinning, developing in the twenty, thirty or forty aged persons.
For the purpose of the present invention, it is necessary to consider various types of hair, including terminal hair, vellus hair, and modified terminal hair such as in the eyebrows and eyelashes. Terminal hairs are coarse, pigmented, long hairs in which the bulb of the hair follicle is situated deep in the dermis. Vellus hairs, on the other hand, are fine, thin, non-pigmented short hairs in which the hair bulb is located superficially in the dermis. As alopecia progresses, a transition takes place in the area of approaching baldness wherein the hairs themselves are changing from the terminal to the vellus type. The size of the hair follicles is known to decrease.
Another factor that contributes to the end result is a change in the cycle of hair growth. In humans, each hair follicle undergoes repeated cyclical periods of growth. These cycles include anagen, an active growth stage, which can last for ˜2 to 6 years; Catagen, a transition phase, which lasts for only ˜1-2 weeks; and Telogen, a resting period which lasts ˜3-4 months after which the hair is shed and a new hair is grown as the cycle repeats itself. In the normal human scalp, which contains approximately 100,000 hair follicles, 86% of the hair follicles are in Anagen, 1% is in Catagen, and 13% are in Telogen. Thus, under normal conditions, upto approximately 50-100 hairs may shed from the scalp each day. With the onset of male pattern baldness, a successively greater proportion of hairs are in the Telogen phase with correspondingly fewer in the active growth Anagen phase.
While a good deal is known about the results of male pattern baldness, very little is known about the cause. The cause is generally believed to be genetic and hormonal in origin. The known prior arts attempt to control it through hormone adjustment, but this has been singularly unsuccessful. Alopecia is associated with severe diminution of hair follicles. A bald human subject will have an average of only 306 follicles per square centimeter, whereas, a non-bald subject in the same age group will have an average of 460 follicles per square centimeter. This amounts to a one-third reduction in hair follicles which, when added to the increased proportion of vellus hair follicles and the increased number of hair follicles in the Telogen phase, is both significant and noticeable. Approximately, 50% of hair follicles must be shed to produce visible thinning of scalp hair. It is thus a combination of these factors: transition of hairs from terminal to vellus, increased number of Telogen hairs—some of which have been shed, and loss of hair follicles that produce ‘baldness’.
So far, various approaches have been conceived to limit or remedy hair loss.
Surgical Techniques:
                Self-grafting or transplants—Hair bulbs are drawn from the posterior scalp that is hair-bearing and redistributed in a balding area.        Flap surgery—A large horse shoe-shaped piece of scalp is partially detached from the donor fringe area and the free end is positioned over the bald spot where a corresponding patch of hair less scalp has been removed.        Scalp reductions—A section of bald scalp is removed and the sides of scalp are lifted and sutured together, thereby reducing the overall surface area of the scalp.        Scalp expansion and extension—Silicon bags are inserted beneath an area of hairy scalp and gradually inflated with saline water over a 6 week period. This causes the hair-bearing skin to stretch, thus increasing the amount of hair-bearing scalp. After removing the bags, expanded hair-bearing skin is lifted and moved to an adjacent bald area where similar sized patch of scalp has been excised.        
Even though the use of laser and particular non-cicatrizing substances has reduced many chances of cicatrization, the surgical methods are costly, traumatic, painful and produce undesired side effects.
Non-Surgical Techniques:
These include additions of hair-bearing devices that can consist of human hair, synthetic fibre or a combination of both. These additions are attached by a variety of techniques, either the existing hair or skin being possible anchoring sites.
Medicinal Treatments:
Medicinal treatments include topical application of vasodilators like minoxidil, diazoxide etc. which cause the reactivation of cutaneous blood flow, thus producing the influx of oxygen and nutrients necessary for regeneration of tissues. One of the medications uses minoxidil as its active ingredient and is sold under the trade name Rogaine (a trademark of Pharmacia and Upjohn Company). Rogaine has shown to reduce hair loss and stimulate hair growth in upto 10% of men with male pattern baldness. Treatment with it though has to be exhaustively and regularly maintained. It is also very expensive. The topical application of substances used so far makes the ability of cutaneous absorption limited and superficial: that is unavoidable, given that, if the vasodilators should be absorbed in a massive manner, undesired systemic effects would arise.
Certain antiandrogens like Spironolactone, Aldactone, Cimetidine, or 5-alpha reductase inhibitors like oral Finasteride are known to avoid the transformation of testosterone to DHT which is responsible for hair loss. Finasteride is an active ingredient in Propecia (a trademark of Merck and Co. inc.) in pill form and has to be taken regularly. A drawback of antiandrogen therapy is that it is hard to restrict androgen blockage to the scalp only, thus causing undesired effects especially in men (decreased libido, impotence, gynaecomastia, etc.)
Thus, with regard to hair loss, the results obtained until now are not entirely satisfactory. Androgens (steroid hormones such as estrogen and testosterone) are the most obvious regulators of human hair growth in both sexes. Interestingly, androgens have contrasting effects on hair follicles depending on the hair follicle's location in the body. Androgens stimulate hair growth in many locations (i.e., beard, axilla) while inhibiting scalp hair growth in genetically predisposed individuals. Androgens act on the hair follicles via the dermal papilla, presumably by altering the production of regulatory factors (growth factors, peptides etc.) that influence the dermal papilla cells. Cultured dermal papilla cells secrete factors which are mitogenic for other dermal papilla cells, outer root sheath cells, epidermal keratinocytes and endothelial cells. Androgen-sensitive cells from beard or balding scalp reflect their in vivo androgenetic responses by responding to testosterone by either increasing (i.e., beard) or decreasing (i.e., balding) their mitogenic ability.
Many growth factors have been implicated in controlling different signals in the cycle of hair growth, with some playing major and some playing minor roles.
An article titled ‘Growth factors and cytokines in hair follicle development and cycling: recent insights from animal models and the potentials for clinical therapy’ by Danilenko et. al. published in Molecular medicine today, Volume 2, issue 11 discloses the importance of growth factors and cytokines in hair follicle development and cycling.
U.S. Pat. No. 5,538,945 relates to method for stimulating hair-growth in an animal by administering an effective amount of peptide copper complexes.
An article titled ‘The effect of tripeptide-copper complex on human hair growth in vitro’ By Pyo H K et. al. published in Arch Pharm Res. in 2007 discloses the effects of L-alanyl-L-histidyl-L-lysine-Cu2+ (AHK-Cu) on human hair growth ex vivo and cultured dermal papilla cells. The results indicate that AHK-Cu promotes the growth of human hair follicles.
An article titled ‘Control of hair growth and follicle size by VEGF-mediated angiogenesis’ by Yano K et. al. published in J Clin Invest. 2001 February; 107(4):409-17 identifies VEGF as a major mediator of hair follicle growth and cycling and provides the evidence that improved follicle vascularization promotes hair growth and increases hair follicle and hair size.
WO/2007/102686 relates to a peptide having the activity of Insulin like growth factor-1 and a composition for improving skin conditions for treating a periodontal disease comprising the peptide.
An article titled ‘Igf-I signaling controls the hair growth cycle and the differentiation of hair shafts’ by Weger et. al. published in J Invest Dermatol. 2005 November; 125(5):873-82 discloses the effects of Igf-I on follicular proliferation, tissue remodeling, and the hair growth cycle, as well as follicular differentiation.
An article titled ‘Insulin-like growth factor 1 and hair growth’ by Su el. al. published in Dermatology Online J. 1999 November; 5(2):1 discloses the effects of IGF-1 on follicle cell proliferation and differentiation, particularly, the paracrine versus endocrine action of IGF-1 on hair growth.
An article titled ‘Hair growth induction: roles of growth factors’ by Moore et. al. published in Ann NY Acad Sci. 1991 Dec. 26; 642:308-25 discloses the role of epidermal growth factor and fibroblast growth factor on hair growth induction.
An article titled ‘Keratinocyte growth factor is an important endogenous mediator of hair follicle growth, development, and differentiation. Normalization of the nu/nu follicular differentiation defect and amelioration of chemotherapy-induced alopecia’ by D. M. Danilenko et. al. published in Am J Pathol. 1995 July; 147(1): 145-154 investigates the effects of Keratinocyte Growth Factor on hair follicles in two distinct murine models of alopecia.
Despite the widespread occurrence of alopecia, especially androgenetic alopecia, the need for prevention and therapy still exists. There is a lot of ongoing research world over to develop a wonderdrug to treat this problem, though treatments from medications to surgery are currently available. However, not many benefit from existing treatments, sometimes they just do not work, there are a large number of unsatisfactory results, some patients are not suitable for available therapies, cost is huge for surgeries, results are not long lasting, side effects are a concern, etc. Therefore, there is still a need in the art for improved composition capable of preventing hair loss and stimulating hair growth.
It is therefore a principal object of the present invention to provide an intradermal pharmaceutical composition for effective treatment for prevention of hair loss and for stimulation of hair regrowth which is apparently non-toxic and relatively free of unwanted side effects.
Another object of the invention is to provide a treatment for male pattern alopecia which is safe, simple, painless, cosmetic in the sense of being invisible, easy to apply, and quite inexpensive when compared to hair transplants and the like.
Thus the invention described herein aims at resolving the problem of hair loss, a phenomenon which affects a wide portion of the population (especially the male one: nearly 2 out of 3 males develop some form of balding).